Safety and Efficacy of Kaletra in ARV Therapy Experienced Patients - Full Text View

Sponsor:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00648999

Purpose

To demonstrate that patients treated with Kaletra have an improvement in their quality of life compared to the quality of life they had with their previous NRTI therapy.

Condition	Intervention	Phase
HIV Infections Kaletra	Drug: lopinavir/ritonavir Drug: lopinavir /ritonavir	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase IV Non Randomized Study in ARV Experienced Patients Under Switch Therapy With Kaletra

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Ritonavir Lopinavir

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

Quality of Life [ Time Frame: Baseline, Week 4, Week 24 and Week 48 ] [ Designated as safety issue: No ]
CD4 [ Time Frame: Baseline, Week 24 and Week 48 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Adverse Event Monitoring [ Time Frame: Baseline, Week 4, Week 24 and Week 48 ] [ Designated as safety issue: No ]

Enrollment:	207
Study Start Date:	November 2003
Primary Completion Date:	December 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1	Drug: lopinavir/ritonavir lopinavir/ritonavir 400 mg/100 mg bid 48 weeks of treatment Other Names: ABT-378 Kaletra lopinavir/ritonavir
Active Comparator: 2	Drug: lopinavir /ritonavir lopinavir/ritonavir 400 mg/100 mg bid 48 weeks of treatment Other Names: ABT-378 Kaletra lopinavir/ritonavir

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

HIV Infected subjects
Subjects failing in current HIV treatment, or
Subjects with a viral load < 400 copies/mL and not tolerating their current HIV treatment.

Exclusion Criteria:

Subject is currently participating in another clinical study or has participated in another clinical study within 30 days prior to screening visit
Subject is pregnant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00648999

Locations

Mexico

Tuxtla Gutierrez, Chiapas, Mexico

Mexico City, Distrito Federal, Mexico

Leon, Guanajauto, Mexico

Acapulco, Guerrero, Mexico

Morelia, Michoacan, Mexico

Cuernavaca, Morelia, Mexico

Tepic, Nayarit, Mexico

Monterrey, Nueva Leon, Mexico

Culiacan, Sinaloa, Mexico

Merida, Yucatan, Mexico

Oaxaca, Mexico

Puebla, Mexico

Sponsors and Collaborators

Abbott

More Information

No publications provided

Responsible Party:	Max Saráchaga / Medical Director, Abbott
ClinicalTrials.gov Identifier:	NCT00648999 History of Changes
Other Study ID Numbers:	MEXI-P01-02
Study First Received:	March 28, 2008
Last Updated:	March 31, 2008
Health Authority:	Mexico: Federal Commission for Sanitary Risks Protection

Keywords provided by Abbott:

HIV

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Ritonavir

Lopinavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012